The emergence of the severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) in the final months of 2019 had the health officials declare a public emergency raising a global response. In response to the burden of the current pandemic, strict measurements were globally implemented to stop further transmission of the virus. These Measurements rely on an accurate diagnosis of individuals infected with the virus by using real-time reverse transcriptase PCR (RT-PCR). The goal of our study is to relate the fundamental clinical and analytical performance of chosen kits of RT-PCR from distinct manufacturers.
A total of 94 nasopharyngeal and oropharyngeal clinical samples were selected randomly, these samples were previously confirmed as 64 positives, and 30 negatives for SARS-COV-2. Generally, 400 µl of each respiratory specimen was subjected to extraction using ExiPrep 96 Viral RNA Kit with the ExiPrep 96 Lite Automated NA Purification System. All kits master mix preparation, cycling protocol, and results interpretation were carried out according to the manufactures’ instructions of use and recommendations.
In our study, we were able to evaluate the performance of 12 commercial kits in detecting SARS-COV-2 using 5 different targets. The performance of the kits was comparable except for LYRA kit as it was less sensitive (F=67, P <0.001). Particularly, the performance of RealStar, BGI, DiaPlexQ, Genesig, LightMix, TaqPath, and RADI kits were the most sensitive. Moreover, the performance of these commercial kits by gene target showed no significant change in Ct values which indicates that kits disparities are mainly linked to the choice of the gene target (F=0.49, P=0.73).
We believe that most of the commercially available RT-PCR kits included in this study can be used for routine diagnosis of SARS-COV-2 patients. Moreover, we recommend that regardless of the laboratory choice of diagnostic commercial kit for the clinical detection of COVID-19 patients the need a for good plan for validation and collaboration with exterior laboratories is essential in order to monitor the virus changes overtime, procedures, technicians, and the different kits performances.